Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00279045
First received: January 17, 2006
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Rosiglitazone
Drug: glyburide
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time from randomization to the primary action point (monotherapy failure). [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP). [ Designated as safety issue: No ]

Enrollment: 4426
Study Start Date: January 2000
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosiglitazone Drug: glyburide Drug: metformin
    Other Names:
    • glyburide
    • Rosiglitazone
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Newly diagnosed patients (< 3years) with type 2 diabetes.
  • Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
  • No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

  • History of lactic acidosis.
  • Anemia (<11g for males, <10 g for females).
  • Unstable or severe NY Heart Association-class 3 or 4.
  • Any NY Heart Association congestive heart failure.
  • Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279045

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Locations
United States, Alabama
GSK Investigational Site
Anniston, Alabama, United States, 36207
GSK Investigational Site
Birmingham, Alabama, United States, 35233
United States, Arizona
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Mesa, Arizona, United States, 85206
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Tucson, Arizona, United States, 85723
United States, Arkansas
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Little Rock, Arkansas, United States, 77205
United States, California
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Berkeley, California, United States, 94705
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Corona, California, United States, 92879
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Fair Oaks, California, United States, 95628
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Fremont, California, United States, 94538
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Fresno, California, United States, 93720
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Fullerton, California, United States, 92835
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Greenbrae, California, United States, 94904
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Harbor City, California, United States, 90710
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Healdsburg, California, United States, 95448
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La Jolla, California, United States, 92037
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Loma Linda, California, United States, 92354
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Los Angeles, California, United States, 90059
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Los Angeles, California, United States, 90095
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Modesto, California, United States, 95355
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Pasadena, California, United States, 91105
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San Diego, California, United States, 92126
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San Francisco, California, United States, 94143
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Santa Rosa, California, United States, 95405
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Sunnyvale, California, United States, 94086
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Ukiah, California, United States, 95482
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Walnut Creek, California, United States, 94598
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Yorba Linda, California, United States, 92886
United States, Colorado
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Boulder, Colorado, United States, 80304
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Denver, Colorado, United States, 80209
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Denver, Colorado, United States, 80220
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Englewood, Colorado, United States, 80110
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Longmont, Colorado, United States, 80501
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Wheat Ridge, Colorado, United States, 80033
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Wheat Ridge, Colorado, United States, 80043
United States, District of Columbia
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Washington, District of Columbia, United States, 20003
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Washington, District of Columbia, United States, 20037
United States, Florida
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Fort Myers, Florida, United States, 33907
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Hollywood, Florida, United States, 33023
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Jacksonville, Florida, United States, 32204
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Jacksonville, Florida, United States, 32216
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Melbourn, Florida, United States, 32935
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33176
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Orlando, Florida, United States, 32806
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Palm Harbor, Florida, United States, 34683
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Sarasota, Florida, United States, 34239
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St. Petersburg, Florida, United States, 33702
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St. Petersburg, Florida, United States, 33710
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Tampa, Florida, United States, 33612
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Titusville, Florida, United States, 32796
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30308
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Atlanta, Georgia, United States, 30312
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30328
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Atlanta, Georgia, United States, 30338
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Blue Ridge, Georgia, United States, 30513
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Duhwoody, Georgia, United States, 30338
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Fayetteville, Georgia, United States, 30214
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
United States, Idaho
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Boise, Idaho, United States, 83706
United States, Illinois
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Chicago, Illinois, United States, 60612
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Gurnee, Illinois, United States, 60031
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Springfield, Illinois, United States, 62704
United States, Indiana
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Evansville, Indiana, United States, 47713
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Indianapolis, Indiana, United States, 46202
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Indianapolis, Indiana, United States, 46250
United States, Kentucky
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Lexington, Kentucky, United States, 40504-2681
United States, Louisiana
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Lake Charles, Louisiana, United States, 70601
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New Orleans, Louisiana, United States, 70119
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Slidell, Louisiana, United States, 70458
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Slidell, Louisiana, United States, 70461
United States, Maine
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Bangor, Maine, United States, 04401
United States, Maryland
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Baltimore, Maryland, United States, 21201
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Baltimore, Maryland, United States, 21204
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Baltimore, Maryland, United States, 21205
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Baltimore, Maryland, United States, 21208
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Springfield, Massachusetts, United States, 01199
United States, Michigan
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Ann Arbor, Michigan, United States, 48109
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Detroit, Michigan, United States, 48201
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Lansing, Michigan, United States, 48912
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Royal Oak, Michigan, United States, 48073
United States, Minnesota
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Minneapolis, Minnesota, United States, 55404
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Minneapolis, Minnesota, United States, 55407-3799
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Minneapolis, Minnesota, United States, 55416
United States, Mississippi
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Jackson, Mississippi, United States, 39202
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Olive Branch, Mississippi, United States, 38654
United States, Missouri
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Kansas City, Missouri, United States, 64132
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St. Louis, Missouri, United States, 63110
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St. Louis, Missouri, United States, 63128
United States, Montana
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Billings, Montana, United States, 59102
United States, Nebraska
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Omaha, Nebraska, United States, 68105
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Omaha, Nebraska, United States, 68131
United States, Nevada
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Henderson, Nevada, United States, 89014
United States, New Jersey
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Cherry Hill, New Jersey, United States, 08034
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Cherry Hill, New Jersey, United States, 8034
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
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Albuquerque, New Mexico, United States, 87106
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Albuquerque, New Mexico, United States, 87109
United States, New York
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Albany, New York, United States, 12206
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Bronx, New York, United States, 10461
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Endwell, New York, United States, 13760
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Flushing, New York, United States, 11365
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New York, New York, United States, 10003
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New York, New York, United States, 10010
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New York, New York, United States, 10021
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New York, New York, United States, 10029
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New York, New York, United States, 10032
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Rochester, New York, United States, 14609
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Rochester, New York, United States, 14642
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Syracuse, New York, United States, 13210
United States, North Carolina
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Durham, North Carolina, United States, 27710
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44121
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Cleveland, Ohio, United States, 44195
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Mogadore, Ohio, United States, 44260
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Westlake, Ohio, United States, 44145
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
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Bend, Oregon, United States, 97701
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Eugene, Oregon, United States, 97401
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Portland, Oregon, United States, 97219
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Portland, Oregon, United States, 97239
United States, Pennsylvania
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Downington, Pennsylvania, United States, 19335
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Feasterville, Pennsylvania, United States, 19053
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Fleetwood, Pennsylvania, United States, 19522
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Hermitage, Pennsylvania, United States, 16148
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Hershey, Pennsylvania, United States, 17033
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Jefferson Hills, Pennsylvania, United States, 15025
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19115
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Philadelphia, Pennsylvania, United States, 19148
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Pittsburgh, Pennsylvania, United States, 15219
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Upland, Pennsylvania, United States, 19013
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Warminster, Pennsylvania, United States, 18974
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West Chester, Pennsylvania, United States, 19380
United States, South Carolina
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Charleston, South Carolina, United States, 29403
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Columbia, South Carolina, United States, 29201
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Greer, South Carolina, United States, 29651
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Spartanburg, South Carolina, United States, 29303
United States, Tennessee
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Bristol, Tennessee, United States, 37620
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Nashville, Tennessee, United States, 37211
United States, Texas
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Arlington, Texas, United States, 76014
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Austin, Texas, United States, 78745
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Beaumont, Texas, United States, 77701
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Corpus Christi, Texas, United States, 78411
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Corpus Christi, Texas, United States, 78412
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75390
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Fort Worth, Texas, United States, 76107
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Houston, Texas, United States, 77024
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Houston, Texas, United States, 77030
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Irving, Texas, United States, 75061
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Midland, Texas, United States, 79705
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San Antonio, Texas, United States, 78207
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San Antonio, Texas, United States, 78229
United States, Utah
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Ogden, Utah, United States, 84403
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Salt Lake City, Utah, United States, 84103
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Salt Lake City, Utah, United States, 84108
United States, Virginia
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Charlottesville, Virginia, United States, 22908
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Newport News, Virginia, United States, 23606
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Richmond, Virginia, United States, 23249
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Salem, Virginia, United States, 24153
United States, Washington
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Federal Way, Washington, United States, 98003
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Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98108
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Seattle, Washington, United States, 98195
GSK Investigational Site
Spokane, Washington, United States, 99204
GSK Investigational Site
Spokane, Washington, United States, 99207
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Spokane, Washington, United States, 99208
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Wenatchee, Washington, United States, 98801
United States, West Virginia
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Charleston, West Virginia, United States, 25304
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Huntington, West Virginia, United States, 25701
United States, Wisconsin
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Madison, Wisconsin, United States, 53717
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Milwaukee, Wisconsin, United States, 53209
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Oregon, Wisconsin, United States, 53575
Austria
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Vienna, Austria, A-1080
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Vienna, Austria, A-1130
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Wiener Neustadt, Austria, A-2700
Belgium
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Blankenberge, Belgium, 8370
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Boechout, Belgium, 2530
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Deurne, Belgium, 2100
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Leuven, Belgium, 3000
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Lubbeek (Linden), Belgium, B-3210
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Tielt, Belgium, 8700
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Wezembeek-Oppem, Belgium, 1970
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Wijnegem, Belgium, 2110
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Zemst, Belgium, 1980
Canada, Alberta
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Calgary, Alberta, Canada, T2R 0X7
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Edmonton, Alberta, Canada, T5N 3Y6
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Edmonton, Alberta, Canada, T6G 2C8
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Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
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Coquitlam, British Columbia, Canada, V3K 3P4
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Vancouver, British Columbia, Canada, V5Z 1M9
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Victoria, British Columbia, Canada, V8R 6T9
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, New Brunswick
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Cambellton, New Brunswick, Canada, E3N 3S8
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Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Antigonish, Nova Scotia, Canada, B2G 2C2
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L5M 2N1
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Oakville, Ontario, Canada, L6H 3P1
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Ottawa, Ontario, Canada, K1H 7W9
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Sudbury, Ontario, Canada, P3A 1Y8
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Thornhill, Ontario, Canada, L4J 1V8
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Thunder Bay, Ontario, Canada, P7B 2Z3
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Timmins, Ontario, Canada, P4N 8P2
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Toronto, Ontario, Canada, M5C 2T2
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Windsor, Ontario, Canada, N8X 1K4
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 1L2
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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La Malbaie, Quebec, Canada, G5A 1W7
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Laval, Quebec, Canada, H7T 2P5
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H2W 1T8
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Plessisville, Quebec, Canada, G6L 3J1
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Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
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Sainte-Foy, Quebec, Canada, G1V 4G5
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Sherbrooke, Quebec, Canada, J1H 5N4
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St-Isidore de Dorchester, Quebec, Canada, G0S 2S0
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
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Saskatoon, Saskatchewan, Canada, S7N 0W8
Czech Republic
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Ostrava, Czech Republic, 703 52
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Phaha 5, Czech Republic, 150 06
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Praha 4, Czech Republic, 142 00
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Usti Nad Labem, Czech Republic, 401 13
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Zlin, Czech Republic, 762 75
Denmark
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Frederiksberg C, Denmark, 1900
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Odense, Denmark, 5000
Finland
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Hanko, Finland, 10900
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Helsinki, Finland, 00150
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Jyvaskyla, Finland, 40100
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Lmatra, Finland, 55800
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Savitaipale, Finland, 54800
France
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Alben, France, 73410
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Bezier, France, 34500
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Bourges, France, 18000
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Brogile, France, 27270
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Chartres, France, 28000
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Denguin, France, 64230
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Evreux, France, 27000
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Gamarde Les Bains, France, 40380
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La Rochelle, France, 17000
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Labarthe Sur Leze, France, 31860
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Le Mans, France, 72000
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Le Pian Medoc, France, 33290
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Lille, France, 59000
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Mallemort, France, 13370
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Marseille, France, 13001
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Marseille, France, 13008
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Marsillargues, France, 34590
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Marssac, France, 81150
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Mont de Marsen, France, 40000
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Montignac, France, 24290
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Moulon, France, 33420
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Murs Erigne, France, 49610
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Nantes Cedex 01, France, 44093
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Nantes, France, 44300
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Nimes, France, 30900
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Orthez, France, 64300
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Paris, France, 75015
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Rennes, France, 35200
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Roanna, France, 42300
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Saint Etienne, France, 42000
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Sisteron, France, 04200
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St Genies Des Fontaines, France, 66740
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St Julien Des Landes, France, 85150
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St Martin D'Heres, France, 38400
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St Pierre de Chandieu, France, 69780
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Strasbourg, France, 67000
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Tarare, France, 69170
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Vieux Conde, France, 59690
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Vourey, France, 38210
Germany
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Bad Rappenau, Baden-Wuerttemberg, Germany, 74906
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Deggingen, Baden-Wuerttemberg, Germany, 73326
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Mannheim, Baden-Wuerttemberg, Germany, 68161
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Trochtelfingen, Baden-Wuerttemberg, Germany, 72818
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Unterschneidheim, Baden-Wuerttemberg, Germany, 73485
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Wangen, Baden-Wuerttemberg, Germany, 88239
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Weinheim, Baden-Wuerttemberg, Germany, 69469
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Aschaffenburg, Bayern, Germany, 63739
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Haag, Bayern, Germany, 83527
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Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
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Ismaning, Bayern, Germany, 85737
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Krummenaab, Bayern, Germany, 92703
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Kuenzing, Bayern, Germany, 94550
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Landshut, Bayern, Germany, 84028
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Muenchen, Bayern, Germany, 80339
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Muenchen, Bayern, Germany, 80469
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Muenchen, Bayern, Germany, 80805
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Muenchen, Bayern, Germany, 80807
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Muenchen, Bayern, Germany, 80937
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Muenchen, Bayern, Germany, 81379
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Nuernberg, Bayern, Germany, 90427
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Wallerfing, Bayern, Germany, 94574
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Bad Kreuznach, Hessen, Germany, 55545
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Frankfurt, Hessen, Germany, 60326
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Grossalmerode, Hessen, Germany, 37247
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Lollar, Hessen, Germany, 35475
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Offenbach, Hessen, Germany, 63065
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Offenbach, Hessen, Germany, 63067
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Offenbach, Hessen, Germany, 63071
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Offenbach, Hessen, Germany, 63073
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Schaafheim, Hessen, Germany, 64850
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Vellmar, Hessen, Germany, 34246
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Damme, Niedersachsen, Germany, 49401
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Hannover, Niedersachsen, Germany, 30171
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Hannover, Niedersachsen, Germany, 30177
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Hildesheim, Niedersachsen, Germany, 31139
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Lueneburg, Niedersachsen, Germany, 21335
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Paderborn, Niedersachsen, Germany, 33100
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Winsen/Lohe, Niedersachsen, Germany, 21423
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Beckum, Nordrhein-Westfalen, Germany, 59269
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Bergkamen, Nordrhein-Westfalen, Germany, 59192
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Borken, Nordrhein-Westfalen, Germany, 46325
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Dortmund, Nordrhein-Westfalen, Germany, 44137
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Duisburg, Nordrhein-Westfalen, Germany, 47119
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Essen, Nordrhein-Westfalen, Germany, 45130
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Euskirchen, Nordrhein-Westfalen, Germany, 53879
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Goch, Nordrhein-Westfalen, Germany, 47574
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Luedenscheid, Nordrhein-Westfalen, Germany, 58511
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Luenen, Nordrhein-Westfalen, Germany, 44534
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Neuss, Nordrhein-Westfalen, Germany, 41460
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Schwabenheim, Nordrhein-Westfalen, Germany, 55270
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Siegen, Nordrhein-Westfalen, Germany, 57072
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Warendorf, Nordrhein-Westfalen, Germany, 48231
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Deidesheim, Rheinland-Pfalz, Germany, 67146
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Diez, Rheinland-Pfalz, Germany, 65582
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Lambrecht, Rheinland-Pfalz, Germany, 67466
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Rhaunen, Rheinland-Pfalz, Germany, 55624
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Chemnitz, Sachsen, Germany, 09130
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Dresden, Sachsen, Germany, 01187
GSK Investigational Site
Dresden, Sachsen, Germany, 01309
GSK Investigational Site
Freital, Sachsen, Germany, 01705
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Itzehoe, Schleswig-Holstein, Germany, 25524
GSK Investigational Site
Ratzeburg, Schleswig-Holstein, Germany, 23909
GSK Investigational Site
Wahlstedt, Schleswig-Holstein, Germany, 23812
GSK Investigational Site
Wilster, Schleswig-Holstein, Germany, 25554
GSK Investigational Site
Berlin, Germany, 13057
GSK Investigational Site
Berlin, Germany, 13355
GSK Investigational Site
Hamburg, Germany, 22041
GSK Investigational Site
Hamburg, Germany, 22607
Hungary
GSK Investigational Site
Budapest, Hungary, 1076
GSK Investigational Site
Miskolc, Hungary, 3526
Ireland
GSK Investigational Site
Belfast, Ireland, BT16 ORH
GSK Investigational Site
Co. Tipperary, Ireland
GSK Investigational Site
Cork, Ireland
GSK Investigational Site
Dublin, Ireland, 15
GSK Investigational Site
Dublin, Ireland, 24
GSK Investigational Site
Dublin, Ireland, 4
GSK Investigational Site
Dublin, Ireland, 7
GSK Investigational Site
Dublin, Ireland, 8
GSK Investigational Site
Gowran, Ireland
GSK Investigational Site
Kilkenny, Ireland
Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
GSK Investigational Site
Ravenna, Emilia-Romagna, Italy, 48100
GSK Investigational Site
Scandiano (RE), Emilia-Romagna, Italy, 42019
GSK Investigational Site
Rozzano (MI), Lombardia, Italy, 20089
GSK Investigational Site
Acquaviva delle Fonti (BA), Puglia, Italy, 70021
GSK Investigational Site
Catania, Sicilia, Italy, 95100
GSK Investigational Site
Città di Castello (PG), Umbria, Italy, 06012
GSK Investigational Site
Firenze, Italy, 50134
GSK Investigational Site
La Spezia, Italy, 19100
GSK Investigational Site
Lecce, Italy, 73100
GSK Investigational Site
Milano, Italy, 20132
GSK Investigational Site
Palermo, Italy, 90127
GSK Investigational Site
Parma, Italy, 43100
GSK Investigational Site
Perugia, Italy, 06126
GSK Investigational Site
Rovigo, Italy, 45100
GSK Investigational Site
S. Benedetto TR (AP), Italy
GSK Investigational Site
San Giovanni Rotondo FG, Italy
GSK Investigational Site
Sassari, Italy
GSK Investigational Site
Terni, Italy, 05100
GSK Investigational Site
Torino, Italy, 10126
GSK Investigational Site
Udine, Italy, 33100
GSK Investigational Site
Vicenza, Italy, 36100
Netherlands
GSK Investigational Site
De Bilt, Netherlands, 3731 DN
GSK Investigational Site
Den Bosch, Netherlands, 5223 GV
GSK Investigational Site
Geleen, Netherlands, 6166 GR
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Huizen, Netherlands, 1271 BB
GSK Investigational Site
Losser, Netherlands, 7581 BV
GSK Investigational Site
Losser, Netherlands, 7582 BD
GSK Investigational Site
Rijswijk, Netherlands, 2281 AK
GSK Investigational Site
Roelofarendsveen, Netherlands, 2371 RB
GSK Investigational Site
Woerden, Netherlands, 3443 GG
Norway
GSK Investigational Site
Hamar, Norway, 2317
GSK Investigational Site
Paradis, Norway, 5231
GSK Investigational Site
Skedsmokorset, Norway, N-2020
Spain
GSK Investigational Site
Albaida (Valencia), Spain
GSK Investigational Site
Basurto/Bilbao, Spain, 48013
GSK Investigational Site
Benassal (Castellón), Spain, 12160
GSK Investigational Site
Benicasim (Castellón), Spain
GSK Investigational Site
Bilbao, Spain, 48013
GSK Investigational Site
Cartagena, Spain, 30203
GSK Investigational Site
Cáceres, Spain, 10005
GSK Investigational Site
El Palmar (Murcia), Spain, 30120
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Elda-Alicante, Spain, 03600
GSK Investigational Site
Figueras, Spain, 17600
GSK Investigational Site
Gerona, Spain
GSK Investigational Site
Granollers (Barcelona), Spain, 08400
GSK Investigational Site
Jerez (Cadiz), Spain, 11047
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Malaga, Spain, 29009
GSK Investigational Site
Mataro, Spain, 08034
GSK Investigational Site
Merida, Spain, 6800
GSK Investigational Site
Olleria, Valencia, Spain, 46850
GSK Investigational Site
Onda/Castellón, Spain, 12200
GSK Investigational Site
Orihuela (Alicante), Spain, 03314
GSK Investigational Site
Plasencia, Spain, 10600
GSK Investigational Site
Pontevedra, Spain, 36071
GSK Investigational Site
Sagunto/Valencia, Spain, 46520
GSK Investigational Site
San Juan (Alicante), Spain, 03550
GSK Investigational Site
San Vincente Raspeig (Alicante), Spain, 03690
GSK Investigational Site
Sta Coloma de Gramanet (Barcelona), Spain, 08923
GSK Investigational Site
Tenerife, Spain, 38010
GSK Investigational Site
Tereul, Spain, 44002
GSK Investigational Site
Toledo, Spain, 45004
GSK Investigational Site
Torrelavega/Santander, Spain, 39300
GSK Investigational Site
Valencia, Spain, 46017
GSK Investigational Site
Valencia, Spain, 46830
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Valladolid, Spain, 47010
GSK Investigational Site
Vallda (Valencia), Spain
GSK Investigational Site
Villajoyosa - Alicante, Spain, 03570
GSK Investigational Site
Zamora, Spain, 49021
GSK Investigational Site
Zaragoza, Spain, 50003
Sweden
GSK Investigational Site
Alta, Sweden, 138 21
GSK Investigational Site
Degerberga, Sweden, 297 31
GSK Investigational Site
Gimo, Sweden, SE-747 43
GSK Investigational Site
Malmö, Sweden, SE-214 26
GSK Investigational Site
Stockholm, Sweden, SE-114 35
United Kingdom
GSK Investigational Site
Aberdeen, Aberdeenshire, United Kingdom, AB25 2AY
GSK Investigational Site
Sandy, Bedfordshire, United Kingdom, SG19 3JR
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 7AG
GSK Investigational Site
Llanelli, Carmarthenshire, United Kingdom, SA14 8QF
GSK Investigational Site
Warrington, Cheshire, United Kingdom, WA5 1QC
GSK Investigational Site
Bournemouth, Dorset, United Kingdom, BH7 7DW
GSK Investigational Site
Poole, Dorset, United Kingdom
GSK Investigational Site
Barry, Glamorgan, United Kingdom, CF63 4HP
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF14 9BB
GSK Investigational Site
Hemel Hempstead, Hertfordshire, United Kingdom, HP2 4AD
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom, ML6 0JS
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G81 4SA
GSK Investigational Site
Bolton, Lancashire, United Kingdom
GSK Investigational Site
Chorley, Lancashire, United Kingdom, PR7 1NY
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH3 9YW
GSK Investigational Site
Wellingbrough, Northamptonshire, United Kingdom, NN8 4RW
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG3 7DQ
GSK Investigational Site
Haverfordwest, Pembrokeshire, United Kingdom, SA61 1RN
GSK Investigational Site
Frome, Somerset, United Kingdom, BA11 1EZ
GSK Investigational Site
Crawley, Sussex West, United Kingdom, RH10 1LL
GSK Investigational Site
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV21 3SP
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
GSK Investigational Site
Melksham, Wiltshire, United Kingdom, SN12 6UN
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 8TG
GSK Investigational Site
Barnsley, United Kingdom, S70 3RJ
GSK Investigational Site
Bath, United Kingdom, BA2 3HT
GSK Investigational Site
Bradford, United Kingdom, BD7 3EE
GSK Investigational Site
Cardiff, United Kingdom, CF5 4AE
GSK Investigational Site
Co.Antrim, United Kingdom
GSK Investigational Site
Doncaster, United Kingdom, DN1 2EG
GSK Investigational Site
Doncaster, United Kingdom, DN9 1EP
GSK Investigational Site
Gateshead, United Kingdom, NE9 6SX
GSK Investigational Site
Glasgow, United Kingdom, G51 4TF
GSK Investigational Site
Glenrothes, United Kingdom
GSK Investigational Site
Irvine, United Kingdom, KA12 OAY
GSK Investigational Site
Kent, United Kingdom, TN11 9HL
GSK Investigational Site
Leicester, United Kingdom, LE3 8GS
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
London, United Kingdom, W1M 7AB
GSK Investigational Site
Newtownabbey, United Kingdom, BT36 4PP
GSK Investigational Site
Peterborough, United Kingdom, PE7 3JL
GSK Investigational Site
Swansea, United Kingdom, SA4 4BY
GSK Investigational Site
Wakefield, United Kingdom, WF1 4DG
GSK Investigational Site
Wigan, United Kingdom, WN1 1XX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/048
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00279045     History of Changes
Other Study ID Numbers: 49653/048 
Study First Received: January 17, 2006
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
type 2 diabetes monotherapy treatment naive

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 14, 2017